Efficacy of vaginal mussel adhesive protein for treating postmenopausal vulvovaginal atrophy.

OBJECTIVE

To compare the efficacy and safety of the vaginal mussel adhesive protein (MAP) hydrogel with the promestriene or the placebo hydrogel for treating moderate-to-severe postmenopausal vulvovaginal atrophy (VVA) symptoms.

METHODS

This 12-week randomised clinical trial enrolled postmenopausal women with moderate-to-severe VVA to receive treatment with MAP, promestriene or placebo hydrogel. The primary outcome was the decrease in severity of most bothersome symptom (MBS) between baseline and 12 weeks. Additional measures included a composite vaginal symptom index, vaginal health index, female sexual function index (FSFI) score, vaginal pH, vaginal maturation value, vaginal microecology, treatment satisfaction, meaningful benefit and treatment safety.

RESULTS

We recruited 105 participants, and 96 provided data for the study analysis. Three treatments had similar mean reductions in MBS severity over 12 weeks: MAP, -1.72 (95% CI, -1.91 to -1.53); promestriene, -1.55 (95% CI, -1.86 to -1.24) and placebo, -1.71 (95% CI, -1.95 to -1.48). Compared to the placebo, the MAP significantly improved the Satisfaction (P = .003) of the FSFI. In addition, the MAP and promestriene improved the vaginal microecology significantly. Adjusted for age and year after menopause, the mean reductions in MBS and the mean improvements in FSFI of MAP were comparable with promestriene (MBS, P = .410; FSFI, P = .233) but greater than the placebo (MBS, P = .028; FSFI, P = .046).

CONCLUSION

After adjusting for age and year after menopause, MAP demonstrates comparable efficacy to promestriene but superior effectiveness to placebo in alleviating postmenopausal vulvovaginal symptoms.